Assessment of Cardiorespiratory Fitness Using the PACER in Patients With Juvenile Idiopathic Arthritis and Familial Mediterranean Fever

NCT ID: NCT06697028

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 216 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-25
• Study Completion Date: 2025-05-11

Brief Summary

Juvenile Idiopathic Arthritis (JIA) and Familial Mediterranean Fever (FMF) are the most common autoimmune and autoinflammatory rheumatic diseases in childhood. Symptoms such as reduced muscle strength, joint pain, fatigue, and limited activity, which are common in childhood rheumatic diseases, often lead to impaired physical function. Cardiorespiratory fitness, which is an important indicator of physical function, plays a critical role in health-related outcomes in children and adolescents with rheumatic disease. Maximum oxygen consumption (VO2 peak) is considered the fundamental criterion for evaluating cardiorespiratory fitness. The need for extensive equipment and trained personnel, accompanied with the inability to assess large numbers of children at one-time makes the objective assessment of cardiorespiratory fitness in a clinic setting unmanageable. Therefore, there is a need to assess their cardiorespiratory fitness utilizing an easily administered test that has minimal measurement errors in patients with JIA and FMF. The Progressive Aerobic Cardiovascular Endurance Run (PACER) has become a routine cardiorespiratory fitness assessment for predicting VO2peak in children. A review of the literature revealed that no studies have evaluated CRF using PACER in childhood rheumatic diseases. The aim of this study was to compare the Fitnessgram VO2 max values of children and adolescents diagnosed with JIA and FMF with those of their healthy peers and to examine the relationship with body composition.

Conditions

Juvenile Idiopathic Arthritis; Familial Mediterranean Fever; Healty Controls

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Juvenile Idiopathic Arthritis

Patients diagnosed with JIA followed at the Pediatric Rheumatology Clinic, Department of Pediatrics, Istanbul Faculty of Medicine, will be evaluated.

Usability and Comparison

Intervention Type: OTHER

PACER will be used to assess cardiorespiratory fitness in individuals with rheumatic diseases. The results will be compared with those of healthy individuals, and the relationship between body composition and VO2 max will be examined.

Familial Mediterranean Fever

Patients diagnosed with FMF followed at the Pediatric Rheumatology Clinic, Department of Pediatrics, Istanbul Faculty of Medicine, will be evaluated.

Usability and Comparison

Intervention Type: OTHER

PACER will be used to assess cardiorespiratory fitness in individuals with rheumatic diseases. The results will be compared with those of healthy individuals, and the relationship between body composition and VO2 max will be examined.

Healthy control

The outcomes of individuals with rheumatic diseases will be compared with those of healthy controls.

Usability and Comparison

Intervention Type: OTHER

PACER will be used to assess cardiorespiratory fitness in individuals with rheumatic diseases. The results will be compared with those of healthy individuals, and the relationship between body composition and VO2 max will be examined.

Interventions

Usability and Comparison

PACER will be used to assess cardiorespiratory fitness in individuals with rheumatic diseases. The results will be compared with those of healthy individuals, and the relationship between body composition and VO2 max will be examined.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Did not have any chronic disease other than rheumatic disease
• Diagnosed with rheumatic disease at least 6 months ago
• Had stable medical treatment
• Being between the ages of 12 and 18
• Volunteering to participate in the study

Exclusion Criteria

• Have experienced trauma or surgery affecting the musculoskeletal system within the last 6 months
• Have acute pain for any reason, have visual or hearing problems
• Have cognitive impairment
• Not volunteering to participate in the study

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Asya Albayrak

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AAlbayrak

Identifier Type: -

Identifier Source: org_study_id